Kerry Mello-Parker, Director of Clinical Compliance for Rare & Complex Therapies, and Shanna Martin, Registered Nurse, from Shields Health Solutions, discuss the Risk Evaluation and Mitigation Strategies (REMS) program for macitentan, a treatment option for patients with pulmonary arterial hypertension (PAH).
PAH is a rare, progressive disorder characterized by high blood pressure (hypertension) in the arteries of the lungs (pulmonary artery). These symptoms arise for no apparent reason. The pulmonary arteries are the blood vessels that carry blood from the right side of the heart through the lungs. Symptoms of PAH include dyspnea, especially during exercise, chest pain, and fainting episodes. The exact cause of PAH is unknown and although treatable, there is no known cure for the disease. PAH usually affects women between the ages of 30-60. The progressive nature of this disease means that an individual may experience only mild symptoms at first, but will eventually require treatment and medical care to maintain a reasonable quality of life.
As Mses. Mello-Parker and Martin explain, a REMS program is a drug safety program that the U.S. Food and Drug Administration (FDA) requires for certain medications that have serious safety concerns. A REMS program helps to ensure the benefits of the medication outweigh the risks.
In the case of PAH, all healthcare providers must enroll in the REMS program for macitentan and comply with its requirements in order to prescribe this medication. All female patients must be enrolled in the macitentan REMS program in order to receive macitentan. Female patients of reproductive potential and pre-pubertal female patients of non-reproductive potential must be counseled on the risks of embryo-fetal toxicity while on macitentan. Female patients of reproductive potential are required to take a monthly pregnancy test.
To learn more about PAH, and other rare heart conditions, visit https://checkrare.com/diseases/heart-diseases/